Ascend Laboratories, Llc: Amlodipine And Olmesartan Medoxomil Tablets, 5mg/40mg
Recall Summary Ascend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (5mg/40mg) in 30-count bottles nationwide because the olmesartan medoxomil content in some tablets is below the required amount. This means affected tablets may not contain the full dose of one of the active ingredients needed for the medication to work as intended. The recall affects patients across all U.S. states and Washington, D.C. who received this prescription blood pressure medication.
- Recalling firm
- Ascend Laboratories, LLC
- Product
- Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30.
- Reason
- Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-05
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S.A. Nationwide
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/90218ce8-1e65-4dd0-be37-3e1c618bf5fa